Lybalvi (olanzapine/samidorphan) / Alkermes 
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 1 Disease   2 Trials   2 Trials   256 News 


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  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Review, Journal:  Olanzapine/Samidorphan: First Approval. (Pubmed Central) -  Dec 22, 2021   
    Olanzapine/samidorphan (LYBALVI) was recently approved in the USA for the treatment of schizophrenia and bipolar I disorder. This article summarizes the milestones in the development of samidorphan leading to this first approval of olanzapine/samidorphan.
  • ||||||||||  Rexulti (brexpiprazole) / Lundbeck, Otsuka
    Review, Journal:  New Antipsychotic Medications in the Last Decade. (Pubmed Central) -  Dec 16, 2021   
    We identified 11 significant developments: the introduction of new antipsychotics cariprazine, brexpiprazole, lumateperone, and pimavanserin; introduction of new delivery subcutaneous long-acting risperidone, aripiprazole lauroxil, transdermal asenapine, and inhaled loxapine; and the introduction of new approaches such as olanzapine/samidorphan for olanzapine-associated weight gain, examination of the TAAR1 agonist SEP 363,856 as a test of concept, and the combination of Xanomeline/Trospium, an M and M muscarinic receptor agonist in conjunction with a peripheral anticholinergic. Last decade has seen a tremendous development in second-generation antipsychotics which provides unprecedented treatment options for clinicians in treating psychosis.
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Enrollment open:  Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (clinicaltrials.gov) -  Oct 26, 2021   
    P3,  N=236, Enrolling by invitation, 
    Samidorphan is well accepted by olanzapine-treated patients. Not yet recruiting --> Enrolling by invitation
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial completion date, Trial primary completion date:  Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) -  Oct 4, 2021   
    P3,  N=500, Enrolling by invitation, 
    Physiologically based pharmacokinetic modeling extended the findings from a clinical study in severe renal impairment to other untested clinical scenarios; these data could be of interest to clinicians treating patients with renal impairment. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Clinical, Review, Journal:  An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder. (Pubmed Central) -  Sep 18, 2021   
    As OLZ/SAM contains the opioid antagonist samidorphan, it is contraindicated in patients using opioids and in those undergoing acute opioid withdrawal. Clinical trial results from more than 1600 subjects support the use of OLZ/SAM as a new treatment option for patients with schizophrenia or BD-I.
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    [VIRTUAL] Olanzapine/Samidorphan Mitigates Weight Gain Across Subgroups of Patients Known to Be at Increased Risk for Weight Gain With Olanzapine Treatment () -  Apr 13, 2021 - Abstract #ASCP2021ASCP_155;    
    Baseline demographics were similar across treatment groups. OLZ/SAM was associated with a lower percent change in weight vs olanzapine at week 24 across all subgroups evaluated, with least squares mean differences (95% CI) of −2.38% (−3.88%, −0.88%) in the overall population, −2.73% (−4.45%, −1.01%) for males (n=391), −1.53% (−4.43%, 1.38%) for females (n=147), −3.43% (−7.00%, 0.13%) for age <30 years (n=98), −2.14% (−3.78%, −0.51%) for age ≥30 years (n=440), −2.37% (−4.10%, -0.63%) for black patients (n=392), −2.41% (−5.28%, 0.46%) for non-black patients (n=146), −2.17% (−4.10%, −0.24%) with BMI <27 kg/m2 (n=327), and −2.70% (−5.01%, −0.39%) with BMI ≥27 kg/m2 (n=211).
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    [VIRTUAL] Olanzapine/Samidorphan Mitigates Weight Gain across Subgroups of Patients Known to Be at Increased Risk for Weight Gain with Olanzapine Treatment () -  Mar 1, 2021 - Abstract #SIRS2021SIRS_174;    
    Relative to olanzapine, the odds ratios (95% CI) for having a ≥10% weight gain from baseline at week 24 with OLZ/SAM treatment were 0.50 (0.31, 0.80) in the overall population, 0.41 (0.23, 0.73) for males, 0.68 (0.30, 1.55) for females, 0.65 (0.25, 1.70) for age <30 years, 0.46 (0.27, 0.78) for age ≥30 years, 0.47 (0.27, 0.82) for black patients, 0.55 (0.24, 1.30) for non-black patients, 0.57 (0.32, 1.00) with BMI <27 kg/m2, and 0.38 (0.16, 0.87) with BMI ≥27 kg/m2. Discussion In this exploratory analysis of the 24-week, phase 3 study of patients with schizophrenia, the combination OLZ/SAM treatment mitigated weight gain associated with olanzapine across several patient subgroups, including groups of patients who are known to be at higher risk for weight gain with olanzapine based on sex, race, age, and baseline BMI.